Study of the utility of BPO products for acne vulgaris on trunk (back and chest)

Acronym

Study of the utility of BPO products for acne vulgaris on trunk

Scientific Title

Study of the utility of BPO products for acne vulgaris on trunk (back and chest)

Scientific Title:Acronym

Study of the utility of BPO products for acne vulgaris on trunk

Region

Japan

Condition

Condition

Acne vulgaris

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Objectives

Narrative objectives1

The objective of this study is to examine the utility of BPO gelacne for vulgaris on trunk (back and chest).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Decrease in the number of inflammatory rashes / during 12 weeks of observation period

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

BPO gel will be applied for 12 weeks.

Interventions/Control_2

Topical antimicrobial agent(Nadifloxacin or Clindamycin) will be applied for 12 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with acne vulgaris who have 10 or more inflammatory rashes on the trunk(Chest or bBack)
2) Patients who provided written informed consent after receiving an explanation of the details of the study
3) Patients aged 16 years old or older at the time informed consent was provided
For patients younger than 20 years old, representatives (parents, etc.) are required to provide informed consent.

Key exclusion criteria

1) Patients who had received treatment for acne vulgaris within one month of the start of the study
2) Patients in whom the study drug is contraindicated
3) Patients with continuous use of non-steroidal anti-inflammatory drugs (ibuprofen, etc.)
4) Pregnant women, those who may be pregnant, lactating women, and women who hope to become pregnant during the study period
5) Patients who were considered inappropriate for the study by an investigator
6) Patients who had participated in other clinical studies and phase IV clinical trials of drugs for acne vulgaris within 6 months of the start of the study